ciprofloxacin and dexamethasone

Generic: ciprofloxacin and dexamethasone

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin and dexamethasone
Generic Name ciprofloxacin and dexamethasone
Labeler amneal pharmaceuticals of new york llc
Dosage Form SUSPENSION/ DROPS
Routes
AURICULAR (OTIC)
Active Ingredients

ciprofloxacin hydrochloride 3 mg/mL, dexamethasone 1 mg/mL

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-831
Product ID 53746-831_718cd533-d887-4ef1-a7d0-fca696242bb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216501
Listing Expiration 2026-12-31
Marketing Start 2024-03-26

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746831
Hyphenated Format 53746-831

Supplemental Identifiers

RxCUI
403908
UNII
4BA73M5E37 7S5I7G3JQL
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ciprofloxacin and dexamethasone (source: ndc)
Generic Name ciprofloxacin and dexamethasone (source: ndc)
Application Number ANDA216501 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53) / 7.5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

53746-831-53 1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53) / 7.5 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

ciprofloxacin hydrochloride (3 mg/mL) dexamethasone (1 mg/mL)

Linked Drug Pages (1)

Ciprofloxacin and Dexamethasone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "718cd533-d887-4ef1-a7d0-fca696242bb2", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["4BA73M5E37", "7S5I7G3JQL"], "rxcui": ["403908"], "spl_set_id": ["55426495-5fd1-44ca-afcc-ffbbb0a0a569"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53)  / 7.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "53746-831-53", "marketing_start_date": "20240326"}], "brand_name": "Ciprofloxacin and Dexamethasone", "product_id": "53746-831_718cd533-d887-4ef1-a7d0-fca696242bb2", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "53746-831", "generic_name": "Ciprofloxacin and Dexamethasone", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin and Dexamethasone", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "3 mg/mL"}, {"name": "DEXAMETHASONE", "strength": "1 mg/mL"}], "application_number": "ANDA216501", "marketing_category": "ANDA", "marketing_start_date": "20240326", "listing_expiration_date": "20261231"}